NCT02740452

Brief Summary

The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique. The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 15, 2022

Status Verified

June 1, 2021

Enrollment Period

6.3 years

First QC Date

March 25, 2016

Last Update Submit

March 14, 2022

Conditions

Anterior Cruciate Ligament Rupture

Keywords

RuptureAnterior Cruciate Ligament (ACL)Laxity kneeInstability knee

Outcome Measures

Primary Outcomes (1)

  • Measuring anterior knee laxity with KT 1000 arthrometer

    at 12 months

Secondary Outcomes (3)

  • Tegnér scores

    at 12 months

  • Lysholm scores

    at 12 months

  • IKDC score safety

    at 12 months

Study Arms (2)

Ligamys technique

OTHER

Ligamys technique (device) or standard technique

Device: ligamys technique

standard technique

OTHER

Ligamys technique (device) or standard technique

Other: standard technique (anatomic reconstruction)

Interventions

ligamys techniqueDEVICE

Ligamys technique (device) or standard technique

Ligamys technique
standard technique (anatomic reconstruction)OTHER

Ligamys technique (device) or standard technique

standard technique

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 35 years
  • Primary Anterior Cruciate Ligament rupture
  • signed patient consent
  • surgery 21 days or less after traumatism for Ligamys technique

You may not qualify if:

  • infection of the operating site
  • previous osseous disease
  • pregnant or nursing woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesRupture

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Stéphane DESCAMPS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2016

First Posted

April 15, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

March 15, 2022

Record last verified: 2021-06

Locations

FR(1)